CytoDyn Inc. has announced encouraging preliminary results from a preclinical study evaluating leronlimab, a CCR5 antagonist, in a mouse model of MASH (Metabolic Dysfunction-Associated Steatohepatitis). The study, conducted by SMC Laboratories, assessed the optimal dosing of leronlimab and its potential synergies with Resmetirom, the only FDA-approved therapy for MASH.
The preliminary review of the study results indicates that leronlimab monotherapy at a dose of 700 mg demonstrated statistically significant fibrosis reversal compared to an isotype IgG4 control arm (p<0.01). This suggests a potential therapeutic benefit of leronlimab in addressing liver fibrosis, a key complication of MASH.
Dose-Dependent Anti-fibrotic Activity
The study also explored the dose-dependent effects of leronlimab. The data suggest that leronlimab monotherapy exhibits anti-fibrotic activity in a dose-dependent manner, with the 700 mg dose performing better at reversing liver fibrosis compared to the 350 mg dose. This finding warrants further investigation to optimize the dosing regimen for maximum therapeutic efficacy.
Leronlimab vs. Resmetirom
Notably, leronlimab monotherapy (700 mg) appeared to have better anti-fibrotic activity compared to Resmetirom (p=0.057). While this result approaches statistical significance, it suggests that leronlimab could potentially offer a more effective treatment option for liver fibrosis in MASH patients. Resmetirom is currently the only approved therapy for MASH, highlighting the unmet need for more effective treatments.
"These initial results are very exciting and confirm our belief that leronlimab has the potential to be materially beneficial for patients suffering from a number of medical concerns," said Dr. Jacob Lalezari, CEO of CytoDyn. "While additional research is necessary to confirm and explore these findings further, we are very encouraged about the potential for leronlimab to support therapeutics meant to address MASH and specifically fibrosis and related complications in the liver."
CytoDyn is currently in discussions with SMC Laboratories regarding the next steps, including supplemental lab studies to expand on these promising findings, further explore potential synergies, and continue to advance the Company’s clinical pipeline. The company aims to further investigate the potential of leronlimab in addressing MASH and related liver complications through these additional studies.
